Transvaginal Mesh

During the Inaugural proceedings of our President, Barack H. Obama, we the people heard repeatedly the mention of Life, Liberty, and The Pursuit of Happiness as being "the certain unalienable rights of every American citizen".

How could this possibly be achieved when an agency of our government (the Food and Drug Administration), has cleared and unleashed potentially dangerous medical devices for use on our citizens? These devises have caused the destruction of lives, the revocation of liberty, and made the pursuit of happiness impossible!

These behaviors MUST CEASE NOW! All potentially dangerous medical devices such as polypropylene transvaginal mesh products, approved under the F.D.A.'s 510K approval process, MUST be removed from the market immediately!

The 510K process grants "piggybacked" clearances as a result of a "same as or similar to" determination. Case in point: Boston Scientifics' ProteGen Sling , the "predicate device", to multiple polypropylene mesh devices, was voluntarily recalled by Boston Scientific due to "safety concerns". Any testing on these types of products has been shoddy and incomplete, at best. The reason for this has been described as "a rush to market to beat the competition". Yet the devices that followed this "predicate" still remain on the market, and are currently being used by the medical community.

These devices are ruining lives and taking away peoples liberty. They are making them ill, and in many cases bed-ridden. Some women are even becoming suicidal! The victims of these devices and their families are being made miserable. Many of these women are living day to day with major pain. Walking, sitting, standing, riding in a car, anything they do causes pain! They are losing their jobs, their lives (as they have known them) and in some cases, even their homes! Many are unable to care for their children and their homes. They have said that making love with their husbands has become much too painful to endure! The very core of being female has been destroyed by these products that were supposed to make their lives better.

How is any of this right? How is any of this fair? What did these women do to deserve any of this? Anything? Nothing? Then why? Why are these women being made to suffer?

Should not the voluntary recall of the ProteGen Sling have been a "RED FLAG" for the F.D.A., and a signal for them to stop dead in their tracks before allowing anyone else to be further victimized by these faulty products?

We, as the women who have suffered, the families who have lost us, the friends who love us, implore you, our lawmakers, the ones we hold as our leaders, to please make this right. Please do not allow another woman to suffer in the name of greed.

Sincerely,

C. Woolsey

Cynthia WoolseyOlive BranchUser submission

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

Email this article

Transvaginal Mesh

During the Inaugural proceedings of our President, Barack H. Obama, we the people heard repeatedly the mention of Life, Liberty, and The Pursuit of Happiness as being 'the certain unalienable rights